Clinical Trials Directory

Trials / Unknown

UnknownNCT02441049

Latino Mothers as Primary Agents of Change

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
361 (actual)
Sponsor
San Diego State University · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

Summary

Entre Familia was a 4-year randomized controlled trial funded by the American Cancer Society. The study was conducted in Imperial County, California, and involved a partnership between the Institute for Behavioral and Community Health at San Diego State University and Clínicas de Salud del Pueblo, Inc. a private, non-profit corporation providing comprehensive primary care services to residents throughout Imperial and Riverside Counties. The investigators enrolled 361 Latina mothers and one of their children aged between 7 and 13 years old; in 25% of families, the father was also enrolled. Participants were randomly assigned to either an intervention or delayed-treatment control condition. The intervention consisted of a community health worker (or promotora)-delivered home-based intervention to promote healthy eating. The promotoras used a telenovela DVD series and accompanying manual, both written and produced by study staff. The intervention was delivered through 11 home visits and 4 support telephone calls over a 4 month period. Participants in the delayed-treatment condition received intervention materials when evaluation assessments had been completed. Evaluation measures were taken at baseline, 4 months (immediate post-intervention) and 10 months (6-months post intervention). Participants completed a self-report interview with study staff at each time point. Height and weight measurements were also collected for the mothers and children. The primary outcomes were changes in mothers' daily fruit and vegetable intake. Secondary outcomes for mothers, children and fathers included changes in fat intake, sugary beverage intake, parenting strategies, and perceived barriers to healthy eating.

Conditions

Interventions

TypeNameDescription
BEHAVIORALHome-based promotora family interventionA promotora-delivered family intervention in the participant's home. Promotoras used a telenovela-style DVD and accompanying manual to deliver 11 home sessions to the family, and 4 support telephone calls, over a 4 month period.

Timeline

Start date
2007-07-01
Primary completion
2011-02-01
Completion
2020-09-01
First posted
2015-05-12
Last updated
2020-04-21

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02441049. Inclusion in this directory is not an endorsement.